Business updates

The EC has published a Frequently Asked Questions (FAQs) on changes in the legislation with regards to Unique Device Identification (UDI) System under the EU Medical device Regulations 2017/745 and 2017/746.

These new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).

The UDI system will:

• facilitate easier traceability of medical devices

• significantly enhance the effectiveness of the post-market safety-related activities for devices

• allow for better monitoring by competent authorities

• help reduce medical errors and fight against falsified devices

• improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators

The New Rules 

Any manufacturer shall assign a unique UDI to a device and to all higher levels of packaging before placing that device on the market except custom-made medical devices and performance study/ investigational devices. 

The UDI carrier shall be placed on the label of the device and on all higher levels of packaging and in case of reusable devices on the device itself (direct marking).

Frequently Asked Questions

What you need to know!

- What is UDI?

- What is the Basic UDI-DI?

- Which products are subject to the UDI system?

- Who is responsible for placing the UDI carrier on the device itself, on the label and on the package of a device?

- What is the procedure for systems and procedure packs to undergo a UDI registration?

- What is the mandatory deadline for a device to comply with the UDI requirements?

- Are devices, which are compliant with the Medical Device Directives (MDD and AIMDD) and placed on the market after the application date of the Regulations (legacy devices), continue to be subject to UDI requirements?

- What is the role of the UDI issuing entities? Who designates them?

- How should a UDI appear on the label or package of a device?

- Are there any requirements for the PI (Production Identifier) information?

- What changes in the medical device would require a new UDI-DI?

- What are the obligations of economic operators and health institutions in relation to UDI?

- Is the software subject to UDI rules?

- Direct marking of reusable devices.  Are there exemptions?

- Is there an adjunction process for ad-hoc exemptions foreseen for medical devices?

- What are the UDI and device data sets to be provided in EUDAMED?